MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-03-23 for COMPUDENT-STA STA5050-301 manufactured by Milestone Scientific.
[1063088]
A compudent-sta unit was used in conjunction with a wand sta handpiece to perform a dental anesthetic injection. The user installed the wand sta hand piece to the drive unit and performed a successful lower block anesthetic injection. Upon removing the hand piece from the patient's mouth, the needle separated from the hand piece, and lodged in the patient's buccalmucosa. The patient was taken to an oral surgeon, who was unable to locate and remove the needle.
Patient Sequence No: 1, Text Type: D, B5
[8225149]
The hand piece was not returned to milestone for evaluation. Therefore, it is not possible to determine the actual failure mode. Information from the dentist's interview, a review of the product labeling and field return data was used in the analysis of this event. In this case the dentist used a hand piece with a 30 gage 1 inch long needle attached. The product labeling (attached) recommends a hand piece with a 27 gage 1 1/4 inch long needle attached for this type of an injection. Without the actual hand piece, it cannot be determined if the use of the shorter, thinner needle contributed to this adverse event. However, the use of a shorter needle would make recovery of the needle more difficult. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082685-2009-00002 |
| MDR Report Key | 1349718 |
| Report Source | 05,07 |
| Date Received | 2009-03-23 |
| Date of Report | 2009-03-23 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-27 |
| Date Added to Maude | 2009-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN SOLOMON |
| Manufacturer Street | 220 SOUTH ORANGE AVE. |
| Manufacturer City | LIVINGSTON NJ 07039 |
| Manufacturer Country | US |
| Manufacturer Postal | 07039 |
| Manufacturer Phone | 9735352717 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUDENT-STA |
| Product Code | EJI |
| Date Received | 2009-03-23 |
| Model Number | STA5050-301 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE SCIENTIFIC |
| Manufacturer Address | 220 SOUTH ORANGE AVE. LIVINGSTON NJ 07039 US 07039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-23 |